agitation, and dyspnea)., anxiety, restlessness, Terminal illness requiring palliative care, with indications for parenteral midazolam administration for symptom management (e.g.
Conditions
Brief summary
AUC0-90 of midazolam based on serum samples collected at 2, 5, 7, 10, 12, 15, 20, 25, 30, 40, 50, 60, 75, and 90 minutes post-administration.
Detailed description
Tmax, Cmax of midazolam and 1-OH-midazolam, AUC0-90 for 1-OH-midazolam, Metabolic ratio: AUC0-90 (1-OH-midazolam / midazolam)., Injection site discomfort (pain, redness, swelling, itching)., Change in respiratory rate from baseline at 10, 20, 30, 40, 50, 60, 75, and 90 minutes, Change in oxygen saturation from baseline at 10, 20, 30, 40, 50, 60, 75, and 90 minutes, Change in RASS-PAL score from baseline at 10, 20, 30, 40, 50, 60, 75, and 90 minutes, Time and number of repeated administrations of sedative medication within 90 minutes following study drug injection
Interventions
DRUGMidazolam B. Braun 1 mg/ml injeksjons-/infusjonsvæske
DRUGoppløsning
Sponsors
Akershus University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-90 of midazolam based on serum samples collected at 2, 5, 7, 10, 12, 15, 20, 25, 30, 40, 50, 60, 75, and 90 minutes post-administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax, Cmax of midazolam and 1-OH-midazolam, AUC0-90 for 1-OH-midazolam, Metabolic ratio: AUC0-90 (1-OH-midazolam / midazolam)., Injection site discomfort (pain, redness, swelling, itching)., Change in respiratory rate from baseline at 10, 20, 30, 40, 50, 60, 75, and 90 minutes, Change in oxygen saturation from baseline at 10, 20, 30, 40, 50, 60, 75, and 90 minutes, Change in RASS-PAL score from baseline at 10, 20, 30, 40, 50, 60, 75, and 90 minutes, Time and number of repeated administrations of sedative medication within 90 minutes following study drug injection | — |
Countries
Norway
Outcome results
None listed